The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy

June 30, 2019 updated by: Lei Xu, Ningbo No. 1 Hospital

Can Experienced Endoscopy Nurse Participation During Screening Colonoscopy Increase Polyp and Adenoma Detection Rate?:A Prospective Randomized Trial

The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Ningbo NO.1 hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 40-70 average risk screening colonoscopy

Exclusion Criteria:

  • GI Bleeding ;
  • history of colorectal surgery ;
  • inflammatory bowel disease ;
  • colorectal cancer,or polyposis syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endoscopist only
Single inspection by endoscopist during colonoscopy
Procedure: Colonoscopist only
Only Colonosopist Observe during Colonoscopy (single observer)
Procedure: Experienced Endoscopy Nurse Participation
Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)
Experimental: nurse participation
Dual inspection by both an endoscopist and an experienced nurse during colonoscopy
Procedure: Colonoscopist only
Only Colonosopist Observe during Colonoscopy (single observer)
Procedure: Experienced Endoscopy Nurse Participation
Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Polyp detection rate
Time Frame: 1.5 year
1.5 year
adenoma detection rate
Time Frame: 1.5 year
1.5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Advanced polyp detection rate
Time Frame: 1.5 year
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Investigators

  • Study Director: XIAOYUN DING, M.D, Ningbo No. 1 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 30, 2019

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBYY2014001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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